Nagoya – protecting resources with paperwork

10.07.2015 - European Biotechnology Network had the good fortune to moderate the 8th Berlin Conference on IP in Life Science, which this year had a focus on natural products. “That will be interesting,” I thought to myself, thinking about the world of complex structures and challenging development pathways.

“Interesting” soon paled into insignificance as I fell headlong into the tiger trap that is the Nagoya Protocol, coming soon folks to a country near you.

For those of you uninitiated in such matters, the Nagoya Protocol is a global programme with the extremely relevant intention to regulate access to genetic resources and ensure the sharing of benefits arising from their utilisation. Europe, as we recall, knows a thing or two about ‘accessing’ resources from countries beyond its immediate vicinity without the express written consent of their owners and Nagoya is a worthy platform to prevent sticky-fingered organisations from literally vacuuming up local resources and knowhow without a) the locals’ consent and b) full engagement financially and culturally.

A lot of paperwork

This all sounds great and, as usual, the liberation of keen regulators around the world has ensured that it is now massively complicated and is already protecting local resources by ensuring that nobody can be bothered to fill in all the forms to pick a plant or sample the water. This learned column however wants to focus on what happens when Nagoya arrives in Europe, which it will do in October, and has to be implemented.

And when I say implemented, I mean into all legal systems, and Europe has many more of those than a simple headcount of countries. Spain is my favourite example, where Nagoya will be implemented by each of the 17 autonomous communities. So, sampling natural resources in Spain (including those found in marine ecosystems) could involve discussions with ALL the regions in which your bacteria, nematode or plant can be cultivated, and that is a lot of paperwork in a wide variety of dialects.

Europe is woefully underprepared for the level of stringency required by Nagoya, most countries aren’t ready for October because they didn’t pay attention when they should have, which will result in the usual amusing quagmire that Europe is good at creating. If this sounds flippant, perhaps it is, but this column comes in the light of the fact that research into, and commercialisation of natural products has collapsed in the years that have seen increasing regulation on access, with, I recall, a reduction of the big companies active in natural products declining from 13 to 3 (don’t quote me on that exact number but it is close).

The irony is that you only have to step outside your back door to find sufficient genetic resources to last a lifetime of natural product research. You don’t have to go to anywhere exotic (and fill in lots of forms) and European implementation of Nagoya will probably ensure that we all look closer to home in the future.

17.03.2015 You would have to be blind, deaf and living in a hole for the last twenty years to not know that Europe struggles with the whole GMO thing.

Claire Skentelbery, Secretary General of the European Biotechnology Network

Despite a mountain of scientific evidence behind the safe cultivation of genetically modified (GM) crops, the PR bomb dropped by Monsanto all those years ago changed Europe forever, resulting in one of the few areas where a belief in witchcraft seems to carry more weight than scientific evidence.

And the European Parliament has recently achieved the questionable triumph of ensuring that superstition at national level can override scientific review at European level. In November, it backed a plan to allow nations to ban GM crops on their soil, even if they are given approval to be grown in the European Union. This of course means that Europe can proudly approve crops and claim to be at the forefront of food production, while individual countries can proudly tell their voters that they continue to ban the evil that is GM and keep their children safe.

I am no fan of multi-national company shenanigans in their corporate dealings and they can indeed do a professional job in looking shifty, but why not address the company problems directly rather than punishing the science? The problem in preventing cultivation of GM crops, and also preventing their import, goes far beyond the claimed negative environmental impact.

The European agricultural system is incredibly important in food security, cultural identity and also gives us the landscape that we know so well today. It is under immense pressure to produce food at lower costs and with reduced pollution, while maintaining the incredibly high food standards rightly required for consumers (all of which GM technology enables). If you prevent European farmers from raising crops (and animals fed on those crops) with the same resources available to every other farmer in the world, then they will not be able to compete in a very global market. European citizens already use and consume products from genetically modified plants, created outside Europe, and if they make their farmers operate with one arm tied behind their backs, they can expect to eat and use a lot more, because there will be far fewer farmers in Europe.

It comes back to science (as usual) and the big picture behind Europe continuing to resist GM technology within its own agricultural system, despite the fact that it is happy to eat the products. GM crops allow more efficient production, and that means fewer resources required in today's intensive agricultural systems. The environmental impact of farming is immense, whatever the production system, so anything that can reduce inputs required is good for everybody. It is a huge pity that national governments have spoken with a false voice through the European Parliament and put short term votes over the long term positive impact of biotechnology on European agriculture, environment and economy.

25.06.2015 European Biotechnology Network had the good fortune to moderate the 8th Berlin Conference on IP in Life Science, which this year had a focus on natural products. “That will be interesting,” I thought to myself, thinking about the world of complex structures and challenging development pathways. “Interesting” soon paled into insignificance as I fell headlong into the tiger trap that is the Nagoya Protocol, coming soon folks to a country near you.

Claire Skentelbery, Secretary General of the European Biotechnology Network

For those of you uninitiated in such matters, the Nagoya Protocol is a global programme with the extremely relevant intention to regulate access to genetic resources and ensure the sharing of benefits arising from their utilisation. Europe, as we recall, knows a thing or two about ‘accessing’ resources from countries beyond its immediate vicinity without the express written consent of their owners and Nagoya is a worthy platform to prevent sticky-fingered organisations from literally vacuuming up local resources and knowhow without a) the locals’ consent and b) full engagement financially and culturally.

This all sounds great and, as usual, the liberation of keen regulators around the world has ensured that it is now massively complicated and is already protecting local resources by ensuring that nobody can be bothered to fill in all the forms to pick a plant or sample the water (see p. 52). This learned column however wants to focus on what happens when Nagoya arrives in Europe, which it will do in October and has to be implemented.

And when I say implemented, I mean into all legal systems, and Europe has many more of those than a simple headcount of countries. Spain is my favourite example, where Nagoya will be implemented by each of the 17 autonomous communities. So, sampling natural resources in Spain (including those found in marine ecosystems) could involve discussions with ALL the regions in which your bacteria, nematode or plant can be cultivated, and that is a lot of paperwork in a wide variety of dialects.

Europe is woefully underprepared for the level of stringency required by Nagoya, most countries aren’t ready for October because they didn’t pay attention when they should have, which will result in the usual amusing quagmire that Europe is good at creating. If this sounds flippant, perhaps it is, but this column comes in the light of the fact that research into, and commercialisation of natural products has collapsed in the years that have seen increasing regulation on access, with, I recall, a reduction of the big companies active in natural products declining from 13 to 3 (don’t quote me on that exact number but it is close).

The irony is that you only have to step outside your back door to find sufficient genetic resources to last a lifetime of natural product research. You don’t have to go to anywhere exotic (and fill in lots of forms) and European implementation of Nagoya will probably ensure that we all look closer to home in the future.

23.12.2014 We have a new set of European Commissioners, and I thought that in this issue, it would be very nice to have a look at one of them through the lens of biotechnology. Commissioner for Research, Science and Innovation Carlos Moedas is our man, and a quick look at his bio shows that he combines origins in engineering with a career in banking and real estate. You may interpret that as you will in terms of usefulness to the world of science.

Claire Skentelbery, Secretary General of the European Biotechnology Network

I was going to give a detailed analysis of Jean-Claude’s invitation letter to Carlos, but to be honest, it was so full of titles like ‘Commissioner in charge of Better Regulation, Inter-institutional Relations, the Rule of Law and the Charter of Fundamental Rights’ (yes, my friends that is a job) – that I thought we would just write our own letter of appointment to Mr. Moedas so that he knows what he needs to do. Here goes …

Dear Carlos,

You’re becoming a Commissioner in the new EC at a particularly challenging time for the European Union. As well as doing all the standard stuff – such as liking Europe, looking smart on the television and not fiddling expenses – we, the scientific community, would very much like you to prioritise the following activities in your portfolio:

1. Linking together research and infrastructure planning and funding at the European, national and regional levels, so that the next scientific breakthrough can be developed quickly to market/field or patient, rather than floating about until somebody from the US or China decides they will do it instead and the European taxpayer subsidises profits somewhere else and then has to buy the final product.

2. Making the best use of Europe’s brains by opening up the often clogged scientific pipeline between school, university and the wide world of biotech, and ensuring that talents are not lost for any reason throughout careers.

3. Empowering SMEs further to drive innovation into commercial reality, plus recognising where the skills and financial gaps are and plugging them.

4. Stop asking nicely for private investment in science and incentivise it to be an integral part of investment portfolios.

5. Ensure that when you spend public money on science, you spend wisely, spend big and spend consistently – big words and small money do not deliver crops, medicine or energy.

6. Join it all up. In a complex and fast-changing world, the bottlenecks often have little to do with the science and everything to do with a lack of money, regulatory barriers, access to downstream partners and getting the right skills at the right time.

To help you fulfil your responsibilities, the whole scientific community in Europe will guide you on your way. You are just about to find out what a passionate sector you serve. We look forward to working with you on the next step needed by Europe’s scientific community.

28.10.2014 This summer saw the first deadline for the new SME Instrument, and the evaluation feedback from the European Commission could be a wake-up call for small companies across Europe.

Claire Skentelbery, Secretary General of the European Biotechnology Network

The funding programme aims to accelerate SME development and help them bridge the financial valley of death. With up to €5m in funding available and no need for the usual EU consortium, this is a tempting opportunity.

Plenty of SMEs applied, and a select few made it into the €50,000 feasibility stage. However plenty did not and there was some strong feedback from the European Commission on why not, which was unusually direct ("just trying their luck, it's not a lottery"). This could be seen as a critical review of European SMEs in general, as Europe still strives to make viable business from science.

One of the key feedbacks was that SMEs focused too much on the science and not enough on the business, and we have all been around long enough in this sector to know that this is the case in many small companies. Fresh-faced from the lab and secure in the knowledge that their science is amazing, there is often much less attention paid to how you are actually going to sell that science, when it will earn its money, and who will pay for it. And this despite original business plans so big they could stop an elephant. This aspect was further reinforced by evaluator feedback on a lack of knowledge about competitors and just proposing a scientific idea without a pathway mapped out for its commercialisation.

The proposal guide- lines were clear – they asked for specific business information. And applicants would have been wise to recognise the significance of what was requested. The bigger question is, does this reflect the business capability of European biotech SMEs? In building original business plans to gain seed funding, SME founders frequently get professional support, particularly first time CEOs, but are they actually able to implement a plan and turn it into reality? Or do they revert to being awestruck by the science itself, pointing and exclaiming “just look at that, who wouldn’t buy that?” Has the European SME sector managed to mature from its early days in the 1990s, when it really started to blossom as a business platform and suck up money? These are questions that may not bring comfortable thought processes to many, myself included.

However, the SME Instrument, inspired by the SBIR programme in the US, could be a critical tool in forcing the business evolution of SMEs, particularly those piloted by CEOs new to the game. Nothing focuses the mind like chasing money, and if the SME Instrument makes people actually implement the business behind science, then the SMEs that triumph in the much sought-after project applications can only help Europe in its quest for business maturity.

26.06.2014 The launch of Horizon2020 and close of the first deadlines in February has shown the appetite of Europe’s researchers from industry and academia for funding.

Claire Skentelbery, Secretary General of the European Biotechnology Network

A huge number of applications were received, particularly for the two-stage applications, where success rates are as low as 4% for some topics. And pass rates could remain low even at Stage 2.

A silver lining

This is scary news at first glance, but we have to look at it in multiple ways. First, these were the first deadlines after a break between FP7 and H2020, so people had been waiting awhile for the Framework carousel to start turning again. Second, the two-stage application process opens the door to a huge number of speculative attempts at Stage 1, where the application is short. In some ways it’s annoying to think a half-developed idea could beat a carefully crafted effort. Indeed, exactly that has happened to enough EBN Member proposals.

Feeding the European fire

When you look at the big picture, however, you have to feel positive. Horizon 2020 is highly focussed on exploitation and raised impact. If evaluators are spoiled for choice with proposals that can deliver economic returns from biotech, then we can’t complain too much. Goodness knows Europe needs to deliver money back into the system from maturing biotechnology. I’m not talking about the kind of money that comes from the acquisition of an SME for a fraction of the public money that has been poured into making it ripe for purchase, but the genuine maturation of value within Europe. These short Stage 1 proposals also enable people new to EC funding to dip a toe in the water. Much better a failed Stage 1 proposal that gets you thinking about working in partnership and moving your technology forward than no effort at all because a full proposal was too difficult. Failed Stage 1 proposals need to keep their chins up – after all, you’ve started a journey, found some new friends and there are many adventures that beckon.

From small beginnings

The big question coming up is how the new SME Instrument performs. Part of me trembles at the thought of how many applications are cooking and how many will be disappointed. The rest of me is excited – at last, something to drive SMEs forward, masters of their own destiny! We’re cautiously circling the first deadlines in June, and I would imagine that the EC is also waiting with terror in its heart so see what the application process yields, and whether they’ll have to get extra USB sticks out of the cupboard to store all the applications. If you feel any tremors in cyberspace on June 25, you will know the SME Instrument has delivered a bouncing big baby into the nervous arms of its midwife.

20.05.2014 There are sinister moves in the world of data protection, and I need to mobilise you – my crack squad of guerrilla scientists. The EC is showing its ugly face, and it’s going to impact you.

Claire Skentelbery, Secretary General of the European Biotechnology Network

A new data protection regulation is being pushed through by the Commission, and it isn’t fighting fair. This is a regulation, not a directive like the one it replaces, and will be implemented word for word into national law, overwriting years of carefully developed legislation that protects consumers and science.

The regulation frankly sucks, and could have been written by a bunch of monkeys with typewriters. It potentially restricts access to data on a huge scale for research, and displays a profound lack of legal clarity or understanding of data use in science. It is so badly written that it will create legal uncertainty around any research carried out using pseudonimised or sensitive data, threatening products or processes from such research – a real killer for investment and exploitation. It will affect all research, so don’t feel smug if you are reading this from a university.

The ’ugly face’ is the strange situation where amendments from worried national governments appear to be sliding out of text prepared by the European Commission, which is very kindly helping out the current Presidency with some extra admin ’support’. Parliament is also confusing the scandal of data access by government security agencies with the use of data in research, and will vote through a draconian regulation that does nothing to stop the NSA reading your email and everything to stop you using data derived from patients, biobanks, etc.

Many governments oppose this, but run the risk of generating headlines about failing to protect their citizens. As we are close to elections, there is an almost tragic resignation to the fact that this regulation will come into effect, and efforts are being aimed at damage limitation rather than creating something genuinely useful. It is like replacing a brain surgeon with a child holding a blunt spoon. It didn’t always go right before, but it sure as hell is going to go wrong now.

This is a ridiculous and dangerous situation. European Commission, please listen to national concerns and improve this regulation. Make it legally strong, bring in specific, more sophisticated reference to the use of data in science, and listen to the countries that have spent years developing exactly this kind of legislation – they know what they are talking about. You are supposed to serve Europe, not impose your own underdeveloped opinions through a misuse of process.

And you, my fearless warriors, contact your MEP, your national government and your newspapers and tell them what this regulation will do to science in Europe. Make them bold enough to do something about it while they still can. If not, then the last one out of the lab should turn out the lights.

As we all know, the European Commission is under intense pressure to reduce costs and shed the image of being a gravy train. This is a favourite topic at the national level in the ongoing fight against the reign of terror from Brussels.

Claire Skentelbery, Secretary General of the European Biotechnology Network

The irony is that the era of eye­watering salaries and mansions on leafy avenues actually ended some time ago. While there are still plenty of Commission people who live very well ­– courtesy of getting their feet under the table back in the old days – many new staff face short contracts, lower wages and substantially less sexy perks. I am all for the European Commission employing people on a realistic level (i.e. like the rest of us), but I am having problems with additional changes in structure that somebody thought was an 'efficiency'.

One cut too many?

The EC is a huge funding body, driving innovation and industrial development across Europe. To do that, it needs passionate and motivated staff who are integrated into the heart of the scientific process. Based on what I have seen myself and heard from plenty of others, the increased use of external agencies to administer project funding isn’t serving collaborative research well. Sure, the agencies come cheaper and let the EC talk about reducing costs, but the direct result is that you get people paid to administer – not to add value to – world­class research collaborations.

Another irony is that there is a queue of people 10km long wanting to work for the Commission, and it includes talented scientists and project managers. So why make them just administer project reports? Managing collaborative research is really hard, we all know that, so why not invest a bit more to ensure that it actually works? These guys would work on the same salaries as you pay external staff. In fact, I bet that those external staff would jump at the chance to stretch their brains beyond correctly completed personnel tables.

Investing in results

The fact is that the European Commission will always take the heat for national issues. It is a useful whipping boy on any aspect of money because its budgets are so huge, and it always looks shifty because its answers are necessarily complicated. The Commission is not going to win any debates at national level, regardless of how much it cuts budgets, so it should stand up and say that it is proud to have skilled Project Officers working as partners with the projects that it funds. Then those projects have the maximum chance of delivering the results that they were funded to achieve, while the Directorates delivering the funding can also see the fruits of their labour and assess the effectiveness of their policies.

01.04.2014 Shhhhh, is that the sound of a chicken coming home to roost in Switzerland? Worried? If you are a scientist working internationally, you should be – and not just because you want a job in Switzerland.

Claire Skentelbery, Secretary General of the European Biotechnology Network

The result of the recent referendum on quotas for immigrants to the alpine country sounded a lot like the usual grumblings of discontent about how Brussels ruins your life by letting foreigners steal your jobs. Usually things like this have little real fall-out. This time however, there was a potentially disastrous impact for science in Switzerland almost immediately. The failure of the Swiss government to sign a free movement deal with Croatia - a direct result of the referendum - suspended talks for Swiss access to Horizon 2020.

Unintended consequences

I'll bet my last euro that this was not a topic of conversation when Swiss citizens were weighing up how to vote, and it is a massive wake-up call for all of us. The Swiss debate reflects arguments going on in our own countries, and the frankly disgracefully low turn-outs in elections. Voter apathy leaves the floor clear for people with 'interesting' views to shout loudly, and as they also tend to be keen voters, they often win. The Brits reading this will recognise the booming call of the swivel-eyed loon as it stalks the marshes of the south, and know the danger out there in the mist. If you are a scientist anywhere in Europe, you need to stand up and fight for the amazing scientific platform that it brings, and do some shouting of your own on why it is essential to vote to protect it. Switzerland has in fact done us a favour before the impending European elections by providing an example of what happens when you can't be bothered to vote, think that a sensible result must come anyway, or that results won't affect you. European science has already been hit by the repercussions of the Swiss referendum, years before the idiots that drove the yes campaign manage to implement quotas of any description. I want you to promise me now that you will start telling people how the science they need to save their lives, reduce pollution, grow their food and drive their economies (and cars) is delivered by international partnerships - a benefit that greatly outweighs a perceived blight upon their lives from people with different accents who might need to go to the doctor once in a while.

Every voice of reason counts

I also want you to promise that you will cast your vote in the European elections in May. It is time for scientists to rule the world, we can't trust anybody else to do it. As the great popular music combo Faithless would say, "inaction is a weapon of mass destruction". So head for the polls, my fearless warriors, and let the world hear our voice.

17.02.2014 I am spoiled for choice this month on things that make me happy about biotech. Three things have happened across Europe that confirm the field has great people that work hard, recognise the truth when it is kicking you in the ankle and aren’t afraid to try something different.

Claire Skentelbery, Secretary General of the European Biotechnology Network

Putting your money where your mouth was

The first was the news that the late Professor Sir Kenneth Murray, founder of Biogen, left £9m to the Darwin Trust of Edinburgh, and £2m to the Royal Society and various other organisations to support young biologists in doctoral studies. Here is a man who enriched the science and business of biotechnology throughout his career, and is now – even after his death – enabling promising scientists to follow his pathway in the best way … with hard cash. Professor Murray, we salute you and take a good hard stare at all those slightly less-deceased scientists who have made their money from mega-deals and exits. We know who you are, so if you are feeling both generous and perhaps slightly unwell, now is the time to reach for the quill and inkpot and make that gesture. Your kids won’t thank you, but we will.

A little ray of Golden sunshine?

Next is the great news that there is some positive spin in the press on GM crops, or at least something that moves the argument temporarily into a sphere of reality. It is always welcome, even when both sides are masters of the PR (dark) art. People should think about the impact of crops such as Golden Rice on the health of people in economies far different from their own. Block this, actively denying nutrition to millions that need it based on your own principles – when you yourself have enough to eat – and what kind of person are you becoming? Someone who pushes over old people when they are indecisive in queues? Oh wait, that last one was me.

Good things come to those that mess about in labs

If proven to be replicable, the news that stem cells can be created just by dipping blood cells into acid is a great example of two things: (1) that it is critical to persevere with potentially great science, and (2) that you should always dream that you can have a breakthrough doing something really simple. Sometimes life is good like that. So January was generous with great reports (apart from the being dead bit in the first story) and I have demonstrated all the impetuosity of a genius scientist by jamming them all into one test tube and heating it, rather than spreading them out over three sensibly planned columns. See you next time, and let’s hope that the gods of interesting science are as active in February as they were in January.

12.12.2013 Welcome to December, and a rather nautical analogy this month. I don’t mean the title of this piece literally of course – messing with nature is what biotech is supposed to do (in a well thought-out and good way, of course) and I stand up to be counted with all those people who mess about with what nature and evolution have so kindly provided.

Claire Skentelbery, Secretary General of the European Biotechnology Network

I’m referring instead to politicians who are seeking, with the best of intentions, to support the biotech sector and impose their own rather rosy view of what companies should look like. Trying to say what a biotech company should be is like trying to get a straight answer from a 10 year old to the question: “Why the hell did you do that?” You’ll get a different response every time, and it’ll be influenced by the least predictable of factors.

Navigating stormy seas

I have seen a number of politicians confuse high-risk, early-stage biotechs with 100-year-old engineering firms that have a Bentley parked outside. The mission of a biotech company is not to develop a firm with hundreds of employees (although that would be a nice side effect) but to deliver the firm’s technology to its destination. A company is a vessel for the precious technology that it holds. A firm is not the deliverable, but rather the small and leaky boat that must navigate a stormy sea. The current destination may not even be the final one. The goal might for example be a transfer to a larger boat, and a captain with a more luxuriant beard.

Too many politicians view a company’s size and age as the deliverable – but why would this be the case? You might keep your company afloat for 20 years, but if you delivered your product to its destination 10 years ago and you are now just bobbing about, then why does it still exist? If your technology is a platform rather than a product, that is a different question, of course – in that case, the technology is the very fabric of the company. But you can only continue to sail your boat if she is watertight, you have a good set of charts and there is a fair wind in your sails.

An eye on the Horizon

And this is where the politicians have to wise up. Don’t throw grant money at a company with your mission to attend its 20th Christmas party. Instead, give it to the company with a mission to celebrate the successful delivery of its cargo to its destination. And don’t worry about what happens to empty boats lost at sea. There are ZERO examples of successful entrepreneurs retiring and doing nothing. Most just end up building new boats, growing bigger beards and heading off on the next voyage.

So target the cargo, not the boat and those sunny shores of Europe’s biotechdreams won’t be far away. Leave the safety of the harbour and see where your voyage takes you.

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